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Essential Principles of Safety & Performance

What are the Essential Principles?​

The Essential Principles of Safety and Performance are the fundamental safety and performance requirements that all medical devices must meet before they can receive MDMA. They are set out in MDS-REQ 2 and in Annexes 1 and 2 of the Medical Devices Law.

The Essential Principles are closely modelled on the General Safety and Performance Requirements (GSPR) of EU MDR Annex I, with equivalent scope and structure.

General Essential Principles (Annex 1)​

These apply to all medical devices:

  • Devices must not compromise patient/user safety when used as intended
  • Performance and safety must be maintained throughout the device's intended lifetime
  • Risk management must be applied — risks must be reduced as far as possible while maintaining device benefit
  • Devices must be designed to reduce risk of use errors
  • Where a device incorporates a measuring function, accuracy must be appropriate
  • Implantable and long-term contact devices must be compatible with body tissues
  • Devices incorporating software must be validated for safety and reliability
  • Labelling and IFU must provide adequate information for safe use

IVD-specific Essential Principles (Annex 2)​

For IVDs, additional principles apply:

  • Performance characteristics (sensitivity, specificity, accuracy) must be specified and validated
  • Reference intervals and cut-off values must be defined
  • Specimen collection and handling instructions must be provided
  • Results must be clearly interpretable

Demonstrating compliance​

Compliance with each applicable Essential Principle must be demonstrated in the technical file, typically through:

  • Reference to harmonised or SFDA-recognised consensus standards (e.g. ISO 10993, ISO 14971, IEC 60601-1, IEC 62304)
  • Test reports from accredited laboratories
  • Clinical evaluation data
  • Risk management documentation

An Essential Principles checklist or compliance matrix — listing each applicable principle, the method of compliance, and the evidence reference — is a practical way to organise this section of the technical file.

Further reading​